FDA Recall
Terminated
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Recall: Z-0296-2020
·
Initiated October 16, 2018
Recall
- Recall Number
- Z-0296-2020
- Event Number
- 83633
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- DRS
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- October 16, 2018
- Terminated
- June 15, 2021
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Reason
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Action
The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.
Distribution
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Quantity
Total number in recall for all products in dist: 49,130 units